ReceptaBio irá submeter pedido de registro à ANVISA do imunoterápico Balstilimabe para o tratamento do Câncer de Colo de Útero.
O pedido de aprovação acelerada junto ao FDA do Balstilimabe para tratamento de Câncer de Colo de Útero avançado deverá ser apresentado ainda neste semestre. Imediatamente após, a Recepta submeterá pedido de registro à ANVISA.
New Clinical Responses for AGEN1181 Presented at AACR 2021.
Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, today presented new clinical data on AGEN1181, its next-generation anti-CTLA-4 antibody, at the American Association for Cancer Research (AACR), Annual Meeting, from April 10 - 15, 2021.
“The preclinical and translational data in conjunction with our updated clinical data with AGEN1181 alone or in combination with our PD-1, balstilimab, continue to strongly support and differentiate our next-generation CTLA-4 antibody,” said Steven O’Day, MD, Chief Medical Officer of Agenus. “AGEN1181 is showing activity in patients with tumors which typically do not respond to first-generation CTLA-4 and PD-1 antibodies. Equally important, the safety data continues to show no immune mediated hypophysitis, pneumonitis, or hepatitis to date. Given the efficacy and favorable safety profile, we have expanded AGEN1181 into Phase 2 in colorectal cancer patients as a first step in our efforts to expand to additional important cancer indications.”
In two separate presentations at AACR, Agenus showcased the optimal performance of AGEN1181 in relevant models. In addition, as the clinical data matures, additional responses as well as a conversion from a partial response to a complete response, have been observed. The new data announced today include the following clinical responses:
• New partial response in the first melanoma patient treated (monotherapy).
• New conversion to complete response in ovarian cancer patient (AGEN1181 plus balstilimab).
• Partial response in microsatellite stable (MSS) colorectal cancer patient (AGEN1181 plus balstilimab).
• Partial response in PD-L1(-) ovarian cancer patient (AGEN1181 plus balstilimab).
• Partial response in MSS colorectal cancer patient (AGEN1181 plus balstilimab).
• Complete response in PD-L1(-) MSS endometrial cancer patient (monotherapy).
• Complete response by PET in PD-L1(-) MSS endometrial cancer patient (AGEN1181 plus balstilimab).
E-poster presentations were made available on the conference platform on April 10 at 8:30am ET. Posters with accompanying audio will be available for viewing to meeting registrants until June 21.
Session: PO.IM02.10 - Therapeutic Antibodies, Including Engineered Antibodies.
Poster title: Fc-enhanced anti-CTLA-4 antibody, AGEN1181: New mechanistic insights for potent antitumor immunity and combination potential in treatment-resistant solid tumors. Abstract number: 1878. Presenting author: Antoine Tanne, PhD.
Session: PO.IM02.05 - Immune Monitoring / Clinical Correlates
Poster title: Characterization of the pharmacodynamic activity of AGEN1181, an Fc-enhanced CTLA-4 antibody, alone and in combination with the PD-1 antibody balstilimab. Abstract number: 1677. Presenting author: Irina Shapiro, PhD.
In addition, Dr. Steven O’Day, Chief Medical Officer, Dr. Dhan Chand, Scientific Director, Head of Drug Discovery, and Dr. Jennifer Buell, President and COO, at Agenus, participated in a webcast hosted by Dr. Matt Phipps of William Blair on Saturday, April 10, 2021 at 10:30 a.m. ET.
Credits: Agenus Inc. "New Clinical Responses for AGEN1181 Presented at AACR". In Press Releases. 13-April-2021. Published under license.